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Tuesday, August 11, 2009

ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA IN PHARMACEUTICALS MANUFACTURING BY SURFACE SWAB METHOD

Surface swab testing of critical area in the manufacturing and filling
area by assesing the microbial contamination levels of any surface
against the predetermined action levels and efficiency of the operating
procedures in the aseptic areas during the manufacturing the product

UNIT OF RESPONSIBILITY:- QA Executive and trained QA Assistants


PRECAUTIONS:-

a) During the Swab testing the test portions are cleaned thoroughly with suitable

disinfactant to avoId contamination from the solutions used for the test

MATERIAL:-

1 Pre sterilized cotton buds/swabs

2 01 % w/v peptone water which has been previously sterilised

3 Sterilised molten soyabean casien digest agar maintained at a temperature

not below 45 degree C

Note :- The media preparation batch no is given to prepared media


PROCEDURE:-

1 Streak the cotton swab across the surface to be monitored

2 Monitor an area of approximately 100 sq cm with the swab being rotated so

that the entire bud/swab head is used

3 When the area of less than 100 sq cm is monitored due note should be made

of the comparison against the general specification Such monitoring may be

required in certain critical positions within aseptic areas

4 Use the last bud/swab of every set of buds/swabs as control and cross reference

with the sample as positive and negetive control

5 Transfer the swabs/buds into 10 ml of sterile 01 % peptone water

6 Prepare uniform suspension by rotating the tubes in between palms and 1 ml of this

suspension is poured in sterile empty plate Add to it 15 to 20 ml of sterile molten

soyabean casien digest agar

7 Incubate the plates, after solidifying of the medium in bacteriological incubator for 72

hours at 35 deg C to 37 deg C

8 Record the observations in the attachment 1

READING :-

The count is done as number of colony forming units (cfu) observed on the surface of

the agar after every 24 hours till completion of 72 hours of incubation

LIMITS :-1) Manufacturing area : wall : NMT 10 cfu Floor : NMT 20 cfu

2) Storage Area : wall : NMT 10 cfu Floor : NMT 20 cfu

3) Filling area : wall : NMT 05 cfu Floor : NMT 10 cfu

Note : In case the swab testing of the equipment is done after the sterilization
the count per swab should be Nil.

Standard operating procedure SOP for microbiology and aseptic techniques

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